CLASS II Device recall · Reported 20 Aug 2014 · FDA Enforcement Report

Verigene Gram-Negative Blood Culture Nucleic Acid Test recalled

Nanosphere is recalling Verigene Gram-Negative Blood Culture Nucleic Acid Test (Bc-gn), performed using the, distributed in 10 states. The recall was initiated on 17 Apr 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesVERIGENE BC-GN TEST KIT (Catalog Number: 20-005-021). TEST CARTRIDGES: Part Number: 20-006-021, Lot Number: 040214021A, Cartridge Numbers: 02148613 - 02148832, Expiration Date: 9/29/14

Quantity recalled580 test cartridges

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2170-2014
FDA event ID: 68177
Recalling firm: Nanosphere, Northbrook, IL
Classification: Class II
Status: Terminated
Recall initiated: 17 Apr 2014
FDA classified: 8 Aug 2014
Reported: 20 Aug 2014
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

17 Apr 2014	Recall initiated by company
8 Aug 2014	Classified by FDA	+113 days
20 Aug 2014	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Nanosphere has determined that a portion of BC-GN Test Cartridge Lot number 040214021A has an elevated risk for No Call results and False Negative results. The BC-GN Test Cartridge (20-006-021) is distributed as part of the Verigene BC-GN Test Kit (20-005-021), which is labeled as "IVD". Therefore, Nanosphere has initiated a voluntary recall to retrieve the following BC-GN Test Cartridges: Test Ca

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers. BC-GN is performed directly on blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-negative bacteria as determined by gram stain. BC-GN is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, is not used to monitor these infections. Sub-culturing of positive blood cultures is necessary to recover organisms for antimicrobial susceptibility testing (AST), for identification of organisms not detected by BC-GN, to detect mixed infections that may not be detected by BC-GN, for association of antimicrobial resistance marker genes to a specific organisms, or for epidemiological typing. The BC-GN test is performed on the Verigene System platform, which is a fully automated, bench-top, molecular diagnostics workstation consisting of Verigene Reader and a bank of up to 32 Verigene Processor SP units. The System enables the detection of bacterial DNA from blood culture, unformed stool, or nasopharyngeal swab, depending on the test, through automated nucleic acid extraction and hybridization.

Where it was distributed

US Distribution including the states of AZ, CA, FL, MN, MT, NE, NJ, NY, TX and WI

Arizona California Florida Minnesota Montana Nebraska New Jersey New York Texas Wisconsin

Questions about this recall

Why was it recalled?

Which lots are affected?

VERIGENE BC-GN TEST KIT (Catalog Number: 20-005-021). TEST CARTRIDGES: Part Number: 20-006-021, Lot Number: 040214021A, Cartridge Numbers: 02148613 - 02148832, Expiration Date: 9/29/14

Where was it sold?

US Distribution including the states of AZ, CA, FL, MN, MT, NE, NJ, NY, TX and WI

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Nanosphere

All 11

Reported	Class	Recall	Company	Reason	Where
8 Oct 2014Device	CLASS II	Verigene Bc-gp Kit recalled by Nanosphere	Nanosphere	Other	Nationwide
8 Oct 2014Device	CLASS II	Verigene Bc-gn Kit recalled by Nanosphere	Nanosphere	Other	Nationwide
1 Oct 2014Device	CLASS II	The Verigene Gram-Positive Blood Culture Nucleic Acid Test recalled	Nanosphere	Listeria	25 states
1 Oct 2014Device	CLASS II	The Verigene Gram Negative Blood Culture Nucleic Acid Test recalled	Nanosphere	Other	25 states
1 Oct 2014Device	CLASS II	The Verigene Clostridium difficile Nucleic Acid Test recalled	Nanosphere	Other Bacterial Contamination	25 states

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